General Anaesthesia During PregnancyGABINCT07115823
A Longitudinal, Cohort Study Investigating the Impact of General Anaesthetic Caesarean Birth, With or Without ICU Admission, on Maternal Mental Health and Mother/Infant Bonding
An observational study of General Anaesthesia During Pregnancy, run by King's College London at 1 site in United Kingdom.
Trial summary
In the UK, approximately 6000 women every year undergo caesarean sections with general anaesthetic. Additionally, around 1300 women are admitted to Intensive Care Units (ICU) annually, typically due to pregnancy or childbirth complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- General Anaesthesia During Pregnancy
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any woman or birthing person who has undergone a caesarean section with general or neuraxial anaesthesia in a UK based hospital within 12 months postpartum.
Who may be able to join
- 18 years of age and over
- Gave birth by caesarean section (CS) in a UK hospital within the last 12 months
- Able and willing to access the internet
- ICU admission following CS
Who cannot join
- Under 18 years of age.
- Vaginal birth (including instrumental) that did not lead to GACS or NACS
- CS that has not taken place in a UK hospital
- CS more than 12 months ago
- ICU admission immediately following CS outside of the UK.
- Unable to access the internet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Faculty of Life Science and Medicine
London, SE1 7EH
Michelle Anderson, PhD Candidate, 07957955462, michelle.4.anderson@kcl.ac.uk
Dr Hannah Rayment-Jones
About this study
In the UK, approximately 6000 women every year undergo caesarean sections with general anaesthetic. Additionally, around 1300 women are admitted to Intensive Care Units (ICU) annually, typically due to pregnancy or childbirth complications. Some of these women are admitted to ICU for critical care immediately following a general anaesthetic caesarean section. However, there is little research on the impact of these experiences on women/birthing people and their families.
This project aims to explore the impact of general anaesthetic caesarean section, with or without subsequent ICU admission, on a mother's mental health and bonding with her newborn. Women and birthing people who have undergone a caesarean section with an epidural or spinal anaesthesia can also take part in this study, so that outcomes can be compared for different types of caesarean birth.
Read the detailed description
Birth is a dynamic and transformative event, both on an individual and societal level and a key phase in the transition to motherhood. Many women or birthing people remain conscious during childbirth, allowing for immediate interaction and bonding activities with their newborns. However, those who undergo a General Anaesthetic Caesarean Section (GACS) are in a state of controlled unconsciousness due the effects of the general anaesthetic and therefore, will not experience their infant being born or early post-birth interactions.
Additionally, a small proportion of women or birthing people require admission to Intensive Care Units (ICU) following GACS. This can result in more prolonged periods where the mother is unable to emotionally connect or interact with her newborn. Consequently, this may increase the risk of mental health issues and affect bonding experiences for the mother postnatally. Yet, the impact of these events on women and their families remains largely underexplored.
This study Involves a longitudinal survey to collect prospective data on the experience of GACS compared to caesarean sections with neuraxial anaesthesia (NACS), focusing on mental health outcomes and maternal-infant bonding. The survey will include the Depression, Anxiety \& Stress Scale (DASS-21), the City Birth Trauma Scale (CBTS) and the Postpartum Bonding Questionnaire (PBQ) and one question on self-harm from the Edinburgh Postnatal Depression Scale (EPDS). These measures will be collected upon completion of the initial survey and again 3 months later.
- Conditions
- General Anaesthesia During Pregnancy
- Keywords
- General anaesthetic caesarean birth, Maternal mental health, Newborn bonding, Obstetric ICU admission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women or birthing people who have given birth by GACS | Women or birthing people aged 18 or older who have given birth by GACS in a UK hospital, within 12 months postpartum. | |
| Women or birthing people who have given birth by NACS | Women or birthing people aged 18 or older who have given birth by NACS in a UK hospital, within 12 months postpartum. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postnatal depression
Depression scores (DASS-21)
Measured: 1-15 months post birth
Newborn bonding
PBQ scores
Measured: 1-15 months post birth
Secondary outcomes (3)
Anxiety
Anxiety scores (DASS-21)
Measured: 1-15 months post birth
PTSD symptoms
City Birth Trauma Scale scores
Measured: 1-15 months post birth.
Self-harm
Scores from self-harm question on Edinburgh Postnatal Depression Scale
Measured: 1-15 months post birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for General Anaesthesia During PregnancyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellbeing of Women, Burdett Trust for Nursing
- Responsible party
- Sponsor
- Investigators
- Dr Hannah Rayment-Jones, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115823
- Sponsor's protocol ID
- 359600
- Other IDs
- RTF1201, RTF1201
- Acronym
- GABI
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared as participants do not provide consent for the sharing of their data outside the research team, even in anonymised form.
Publications
Wittkowski A, Vatter S, Muhinyi A, Garrett C, Henderson M. Measuring bonding or attachment in the parent-infant-relationship: A systematic review of parent-report assessment measures, their psychometric properties and clinical utility. Clin Psychol Rev. 2020 Dec;82:101906. doi: 10.1016/j.cpr.2020.101906. Epub 2020 Sep 3.
PubMed 32977111Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Jul 18;347(3):194-9. doi: 10.1056/NEJMcp011542. No abstract available.
PubMed 12124409Widstrom AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first hour after birth, underlying implications and clinical practice. Acta Paediatr. 2019 Jul;108(7):1192-1204. doi: 10.1111/apa.14754. Epub 2019 Mar 13.
PubMed 30762247Reck C, Hunt A, Fuchs T, Weiss R, Noon A, Moehler E, Downing G, Tronick EZ, Mundt C. Interactive regulation of affect in postpartum depressed mothers and their infants: an overview. Psychopathology. 2004 Nov-Dec;37(6):272-80. doi: 10.1159/000081983. Epub 2004 Nov 9.
PubMed 15539778Pownall M, Hutter RRC, Rockliffe L, Conner M. Memory and mood changes in pregnancy: a qualitative content analysis of women's first-hand accounts. J Reprod Infant Psychol. 2023 Nov;41(5):516-527. doi: 10.1080/02646838.2022.2052827. Epub 2022 Mar 20.
PubMed 35306947Powell DN, Leonhardt ND. A Longitudinal Examination of Mothers' Early Postnatal Adaptation: Relative Stability Across the First Eight Weeks. Matern Child Health J. 2023 Dec;27(12):2175-2184. doi: 10.1007/s10995-023-03776-4. Epub 2023 Sep 28.
PubMed 37768532NMPA Project Team. National maternity and perinatal audit: clinical report (2019) Based on births in NHS maternity services between 1st April 2016 and 31st March 2017. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk)
NMPA Project Team. National maternity and perinatal audit: clinical report (2021) Based on births in NHS maternity services between 1st April 2017 and 31st March 2018. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk).
Nakic Rados S, Matijas M, Kuhar L, Andelinovic M, Ayers S. Measuring and conceptualizing PTSD following childbirth: Validation of the City Birth Trauma Scale. Psychol Trauma. 2020 Feb;12(2):147-155. doi: 10.1037/tra0000501. Epub 2019 Aug 1.
PubMed 31368743National Maternity and Perinatal Audit Clinical Report 2022 Based on births in NHS maternity services in England and Wales between 1 April 2018 and 31 March 2019 Ref 336 NMPA Clinical Report_2022.pdf (maternityaudit.org.uk).
Neczypor JL, Holley SL. Providing Evidence-Based Care During the Golden Hour. Nurs Womens Health. 2017 Dec;21(6):462-472. doi: 10.1016/j.nwh.2017.10.011.
PubMed 29223210Mehra R, Shebl FM, Cunningham SD, Magriples U, Barrette E, Herrera C, Kozhimannil KB, Ickovics JR. Area-level deprivation and preterm birth: results from a national, commercially-insured population. BMC Public Health. 2019 Feb 27;19(1):236. doi: 10.1186/s12889-019-6533-7.
PubMed 30813938Lovibond SH, Lovibond PF: Manual for the Depression Anxiety Stress Scales . 1995, Sydney , Psychology Foundation of Australia, 2nd.
Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
PubMed 7726811Krawczyk P, Jastrzebska A, Lipka D, Huras H. Pregnancy related and postpartum admissions to intensive care unit in the obstetric tertiary care center - an 8-year retrospective study. Ginekol Pol. 2021;92(8):575-578. doi: 10.5603/GP.a2021.0034. Epub 2021 Apr 12.
PubMed 33844261
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal, Cohort Study Investigating the Impact of General Anaesthetic Caesarean Birth, With or Without ICU Admission, on Maternal Mental Health and Mother/Infant Bonding
- ClinicalTrials.gov ID
- NCT07115823
- Acronym / sponsor ID
- GABI / 359600
- Conditions
- General Anaesthesia During Pregnancy
- Keywords
- General anaesthetic caesarean birth, Maternal mental health, Newborn bonding, Obstetric ICU admission
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Wellbeing of Women, Burdett Trust for Nursing
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the UK, approximately 6000 women every year undergo caesarean sections with general anaesthetic. Additionally, around 1300 women are admitted to Intensive Care Units (ICU) annually, typically due to pregnancy or childbirth complications. Some of these women are admitted to ICU for critical care immediately following a general anaesthetic caesarean section. However, there is little research on the impact of these experiences on women/birthing people and their families.
This project aims to explore the impact of general anaesthetic caesarean section, with or without subsequent ICU admission, on a mother's mental health and bonding with her newborn. Women and birthing people who have undergone a caesarean section with an epidural or spinal anaesthesia can also take part in this study, so that outcomes can be compared for different types of caesarean birth.
Detailed description
Birth is a dynamic and transformative event, both on an individual and societal level and a key phase in the transition to motherhood. Many women or birthing people remain conscious during childbirth, allowing for immediate interaction and bonding activities with their newborns. However, those who undergo a General Anaesthetic Caesarean Section (GACS) are in a state of controlled unconsciousness due the effects of the general anaesthetic and therefore, will not experience their infant being born or early post-birth interactions.
Additionally, a small proportion of women or birthing people require admission to Intensive Care Units (ICU) following GACS. This can result in more prolonged periods where the mother is unable to emotionally connect or interact with her newborn. Consequently, this may increase the risk of mental health issues and affect bonding experiences for the mother postnatally. Yet, the impact of these events on women and their families remains largely underexplored.
This study Involves a longitudinal survey to collect prospective data on the experience of GACS compared to caesarean sections with neuraxial anaesthesia (NACS), focusing on mental health outcomes and maternal-infant bonding. The survey will include the Depression, Anxiety \& Stress Scale (DASS-21), the City Birth Trauma Scale (CBTS) and the Postpartum Bonding Questionnaire (PBQ) and one question on self-harm from the Edinburgh Postnatal Depression Scale (EPDS). These measures will be collected upon completion of the initial survey and again 3 months later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women or birthing people who have given birth by GACS | – | –Women or birthing people aged 18 or older who have given birth by GACS in a UK hospital, within 12 months postpartum. |
| Women or birthing people who have given birth by NACS | – | –Women or birthing people aged 18 or older who have given birth by NACS in a UK hospital, within 12 months postpartum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any woman or birthing person who has undergone a caesarean section with general or neuraxial anaesthesia in a UK based hospital within 12 months postpartum.
Key inclusion criteria (4 listed)
- 18 years of age and over
- Gave birth by caesarean section (CS) in a UK hospital within the last 12 months
- Able and willing to access the internet
- ICU admission following CS
Key exclusion criteria (6 listed)
- Under 18 years of age.
- Vaginal birth (including instrumental) that did not lead to GACS or NACS
- CS that has not taken place in a UK hospital
- CS more than 12 months ago
- ICU admission immediately following CS outside of the UK.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postnatal depression
Time frame: 1-15 months post birth
Depression scores (DASS-21)
Newborn bonding
Time frame: 1-15 months post birth
PBQ scores
3 secondary outcomes
Anxiety
Time frame: 1-15 months post birth
PTSD symptoms
Time frame: 1-15 months post birth.
Self-harm
Time frame: 1-15 months post birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 32977111Wittkowski A, Vatter S, Muhinyi A, Garrett C, Henderson M. Measuring bonding or attachment in the parent-infant-relationship: A systematic review of parent-report assessment measures, their psychometric properties and clinical utility. Clin Psychol Rev. 2020 Dec;82:101906. doi: 10.1016/j.cpr.2020.101906. Epub 2020 Sep 3.
- Background: PubMed 12124409Wisner KL, Parry BL, Piontek CM. Clinical practice. Postpartum depression. N Engl J Med. 2002 Jul 18;347(3):194-9. doi: 10.1056/NEJMcp011542. No abstract available.
- Background: PubMed 30762247Widstrom AM, Brimdyr K, Svensson K, Cadwell K, Nissen E. Skin-to-skin contact the first hour after birth, underlying implications and clinical practice. Acta Paediatr. 2019 Jul;108(7):1192-1204. doi: 10.1111/apa.14754. Epub 2019 Mar 13.
- Background: PubMed 15539778Reck C, Hunt A, Fuchs T, Weiss R, Noon A, Moehler E, Downing G, Tronick EZ, Mundt C. Interactive regulation of affect in postpartum depressed mothers and their infants: an overview. Psychopathology. 2004 Nov-Dec;37(6):272-80. doi: 10.1159/000081983. Epub 2004 Nov 9.
- Background: PubMed 35306947Pownall M, Hutter RRC, Rockliffe L, Conner M. Memory and mood changes in pregnancy: a qualitative content analysis of women's first-hand accounts. J Reprod Infant Psychol. 2023 Nov;41(5):516-527. doi: 10.1080/02646838.2022.2052827. Epub 2022 Mar 20.
- Background: PubMed 37768532Powell DN, Leonhardt ND. A Longitudinal Examination of Mothers' Early Postnatal Adaptation: Relative Stability Across the First Eight Weeks. Matern Child Health J. 2023 Dec;27(12):2175-2184. doi: 10.1007/s10995-023-03776-4. Epub 2023 Sep 28.
- BackgroundNMPA Project Team. National maternity and perinatal audit: clinical report (2019) Based on births in NHS maternity services between 1st April 2016 and 31st March 2017. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk)
- BackgroundNMPA Project Team. National maternity and perinatal audit: clinical report (2021) Based on births in NHS maternity services between 1st April 2017 and 31st March 2018. Royal College of Obstetrics and Gynaecology, London 2019. NMPA Clinical Report 2019.pdf (maternityaudit.org.uk).
- Background: PubMed 31368743Nakic Rados S, Matijas M, Kuhar L, Andelinovic M, Ayers S. Measuring and conceptualizing PTSD following childbirth: Validation of the City Birth Trauma Scale. Psychol Trauma. 2020 Feb;12(2):147-155. doi: 10.1037/tra0000501. Epub 2019 Aug 1.
- BackgroundNational Maternity and Perinatal Audit Clinical Report 2022 Based on births in NHS maternity services in England and Wales between 1 April 2018 and 31 March 2019 Ref 336 NMPA Clinical Report_2022.pdf (maternityaudit.org.uk).
- Background: PubMed 29223210Neczypor JL, Holley SL. Providing Evidence-Based Care During the Golden Hour. Nurs Womens Health. 2017 Dec;21(6):462-472. doi: 10.1016/j.nwh.2017.10.011.
- Background: PubMed 30813938Mehra R, Shebl FM, Cunningham SD, Magriples U, Barrette E, Herrera C, Kozhimannil KB, Ickovics JR. Area-level deprivation and preterm birth: results from a national, commercially-insured population. BMC Public Health. 2019 Feb 27;19(1):236. doi: 10.1186/s12889-019-6533-7.
- NIHR South London Applied Research CollaborationLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared as participants do not provide consent for the sharing of their data outside the research team, even in anonymised form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Hannah Rayment-Jones principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anaesthesia During Pregnancy, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Anderson, PhD Candidate (+447957955462, michelle.4.anderson@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postnatal depression (time frame: 1-15 months post birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07115823, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.